A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD

NCT ID: NCT05972473

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2027-04-30

Brief Summary

The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aflibercept

Drug: Aflibercept 2mg/eye; Intraocular injection

Group Type: ACTIVE_COMPARATOR

Aflibercept Ophthalmic

Intervention Type: DRUG

2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).

IBI302 dose 8mg

Drug: IBI302 8mg/eye; Intraocular injection

Group Type: EXPERIMENTAL

IBI302

Intervention Type: BIOLOGICAL

8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.

Interventions

Aflibercept Ophthalmic

2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).

Intervention Type: DRUG

IBI302

8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent must be obtained prior to study participation;

2. Male or female ≥ 50 years of age at the time of signing the informed consent;

3. Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea;

4. BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.

Exclusion Criteria

1. Ocular disease:

• Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results;
• Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)> 12 optic disc area (DA) on FFA;
• Subretinal hemorrhage area > 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA;
• Fibrosis or atrophy area > 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment);
• Presence of active intraocular or periocular infection or inflammation;

2. Ocular treatment:

• Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline;
• Fundus laser photo-coagulation in the study eye within 90 days prior to baseline;
• Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline;
• History of vitreoretinal surgery, penetrating keratoplasty in the study eye;

3. General condition or treatment:

• Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after standard treatment);
• HbA1c > 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline;
• History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine;
• Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CIBI302A301CN

Identifier Type: -

Identifier Source: org_study_id